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calendar

21,720 catalysts · 4,728 grant · 4,110 device 510k · 3,126 8k filing · 3,118 approval · 2,000 device pma · 2,000 device recall

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2026-08-10: 0 catalysts2026-08-11: 97 catalysts2026-08-12: 19 catalysts2026-08-13: 19 catalysts2026-08-14: 4 catalysts2026-08-15: 0 catalysts2026-08-16: 0 catalysts2026-08-17: 1 catalyst2026-08-18: 2 catalysts2026-08-19: 2 catalysts2026-08-20: 0 catalysts2026-08-21: 0 catalysts2026-08-22: 0 catalysts2026-08-23: 0 catalysts2026-08-24: 0 catalysts2026-08-25: 0 catalysts2026-08-26: 1 catalyst2026-08-27: 1 catalyst2026-08-28: 0 catalysts2026-08-29: 0 catalysts2026-08-30: 0 catalysts2026-08-31: 0 catalysts2026-09-01: 1 catalyst2026-09-02: 0 catalysts2026-09-03: 1 catalyst2026-09-04: 0 catalysts2026-09-05: 0 catalysts2026-09-06: 0 catalysts2026-09-07: 0 catalysts2026-09-08: 0 catalysts2026-09-09: 0 catalysts2026-09-10: 0 catalysts2026-09-11: 0 catalysts2026-09-12: 0 catalysts2026-09-13: 0 catalysts2026-09-14: 0 catalysts2026-09-15: 0 catalysts2026-09-16: 0 catalysts2026-09-17: 0 catalysts2026-09-18: 0 catalysts2026-09-19: 0 catalysts2026-09-20: 0 catalysts2026-09-21: 0 catalysts2026-09-22: 0 catalysts2026-09-23: 2 catalysts2026-09-24: 0 catalysts2026-09-25: 0 catalysts2026-09-26: 0 catalysts2026-09-27: 0 catalysts2026-09-28: 0 catalysts2026-09-29: 0 catalysts2026-09-30: 0 catalysts2026-10-01: 0 catalysts2026-10-02: 0 catalysts2026-10-03: 0 catalysts2026-10-04: 0 catalysts2026-10-05: 0 catalysts2026-10-06: 0 catalysts2026-10-07: 0 catalysts2026-10-08: 2 catalysts2026-10-09: 0 catalysts2026-10-10: 0 catalysts2026-10-11: 0 catalysts2026-10-12: 0 catalysts2026-10-13: 1 catalyst2026-10-14: 1 catalyst2026-10-15: 0 catalysts2026-10-16: 0 catalysts2026-10-17: 0 catalysts2026-10-18: 0 catalysts2026-10-19: 1 catalyst2026-10-20: 2 catalysts2026-10-21: 2 catalysts2026-10-22: 2 catalysts2026-10-23: 1 catalyst2026-10-24: 0 catalysts2026-10-25: 0 catalysts2026-10-26: 1 catalyst2026-10-27: 8 catalysts2026-10-28: 12 catalysts2026-10-29: 21 catalysts2026-10-30: 4 catalysts2026-10-31: 0 catalysts2026-11-01: 0 catalysts2026-11-02: 9 catalysts2026-11-03: 18 catalysts2026-11-04: 22 catalysts2026-11-05: 37 catalysts2026-11-06: 2 catalysts2026-11-07: 0 catalysts2026-11-08: 0 catalysts
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type
  • grant4,728
  • device 510k4,110
  • 8k filing3,126
  • approval3,118
  • device pma2,000
  • device recall2,000
device adverse event
1,000
  • recall973
  • earnings583
  • phase 2 completion172
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Jan 20, 2025

    43
    ›Jan 22, 2025device 510k567d agoHunan Endoso Life Technology Co., Ltd. — Single-Use Digital Flexible Ureteroscope (PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5, PUR12-6, PUR12-S, PUR12-S1, PUR12-S2) (510k cleared)

    Product code: FGB. Advisory committee: Gastroenterology, Urology. Type: Traditional

    full page →fda device 510k ↗
    ›Jan 22, 2025device 510k567d agoNatus Neurology Incorporated — Nicolet EDX (510k cleared)

    Product code: GWF. Advisory committee: Neurology. Type: Special

    full page →fda device 510k ↗
    ›Jan 22, 2025device 510k567d agoArthrex, Inc. — Arthrex NanoScope System (510k cleared)

    Product code: GCJ. Advisory committee: Gastroenterology, Urology. Type: Traditional

    full page →fda device 510k ↗
    ›Jan 22, 2025device 510k567d agoDepuy Ireland UC — EMPHASYS Acetabular System (510k cleared)

    Product code: LPH. Advisory committee: Orthopedic. Type: Special

    full page →fda device 510k ↗
    ›Jan 22, 2025device 510k567d agoCompex, Spol, S.R.O. — JETT Medical II (510k cleared)

    Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional

    full page →fda device 510k ↗
    ›Jan 22, 2025device 510k567d agoBiodynamik, Inc. — XT3 System (510k cleared)

    Product code: JDW. Advisory committee: Orthopedic. Type: Traditional

    full page →fda device 510k ↗
    ›Jan 22, 2025device 510k567d agoIschemaview, Inc. — Rapid Neuro3D (510k cleared)

    Product code: QIH. Advisory committee: Radiology. Type: Traditional

    full page →fda device 510k ↗
    ›Jan 22, 2025device 510k567d agoIndiba S. A. U. — Reverso Pro System (510k cleared)

    Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional

    full page →fda device 510k ↗
    ›Jan 22, 2025device 510k567d agoIcu Medical, Inc. — Rio™ Drug Reconstitution Transfer Device (510k cleared)ICU MEDICAL INC/DE

    Product code: LHI. Advisory committee: General Hospital. Type: Traditional

    full page →fda device 510k ↗
    ›Jan 22, 2025device 510k567d agoPersyst Development Corporation — Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15)) (510k cleared)

    Product code: OMB. Advisory committee: Neurology. Type: Traditional

    full page →fda device 510k ↗
    ›Jan 22, 2025device 510k567d agoSuturion AB — Suture-TOOL System (510k cleared)

    Product code: NEW. Advisory committee: General, Plastic Surgery. Type: Traditional

    full page →fda device 510k ↗
    ›Jan 22, 2025device 510k567d agoEpic Medical Pte. , Ltd. — ZeroClear™ Bag Access (423100) (510k cleared)

    Product code: ONB. Advisory committee: General Hospital. Type: Special

    full page →fda device 510k ↗
    ›Jan 23, 2025approval566d agoBOSENTAN — FDA approvalBOSENTAN

    Sponsor: WATSON LABS INC. Form: TABLET. Route: ORAL

    full page →BOSENTAN →fda approvals ↗
    ›Jan 23, 2025approval566d agoBOSENTAN — FDA approvalBOSENTAN

    Sponsor: WATSON LABS INC. Form: TABLET. Route: ORAL

    full page →BOSENTAN →fda approvals ↗
    ›Jan 23, 2025approval566d agoDEPAKOTE (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

    Sponsor: ABBVIE. Form: CAPSULE, DELAYED REL PELLETS. Route: ORAL

    full page →divalproex sodium DR →fda approvals ↗
    ›Jan 23, 2025approval566d agoDEPAKOTE ER (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

    Sponsor: ABBVIE. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →divalproex sodium DR →fda approvals ↗
    ›Jan 23, 2025approval566d agoDEPAKOTE (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

    Sponsor: ABBVIE. Form: TABLET, DELAYED RELEASE. Route: ORAL

    full page →divalproex sodium DR →fda approvals ↗
    ›Jan 23, 2025approval566d agoLISDEXAMFETAMINE DIMESYLATE — FDA approvalLISDEXAMFETAMINE DIMESYLATE

    Sponsor: ASCENT PHARMS INC. Form: CAPSULE. Route: ORAL

    full page →LISDEXAMFETAMINE DIMESYLATE →fda approvals ↗
    ›Jan 23, 2025device 510k566d agoShenzhen Launch Electrical Co., Ltd. — Rotatable Connector (5944RL) (510k cleared)

    Product code: LDF. Advisory committee: Cardiovascular. Type: Traditional

    full page →fda device 510k ↗
    ›Jan 23, 2025device 510k566d agoZhejiang Seedream Medical Equipment Co., Ltd. — Mobility Scooter (S-01); Mobility Scooter (S-02) (510k cleared)

    Product code: INI. Advisory committee: Physical Medicine. Type: Traditional

    full page →fda device 510k ↗
    ›Jan 23, 2025device 510k566d agoOts Medical , Ltd. — OTS 25-L (100-5) (510k cleared)KAHR medical Ltd

    Product code: MBI. Advisory committee: Orthopedic. Type: Traditional

    full page →fda device 510k ↗
    ›Jan 23, 2025device 510k566d agoShanghai Samedical & Plastic Instruments Co., Ltd. — RF Cannula (510k cleared)

    Product code: GXI. Advisory committee: Neurology. Type: Traditional

    full page →fda device 510k ↗
    ›Jan 23, 2025device 510k566d agoLife Spine, Inc. — ProLift Pivot Expandable Spacer System (510k cleared)

    Product code: MAX. Advisory committee: Orthopedic. Type: Traditional

    full page →fda device 510k ↗
    ›Jan 23, 2025device 510k566d agoAcumed, LLC — Acu-Sinch Knotless Mini (510k cleared)

    Product code: HTN. Advisory committee: Orthopedic. Type: Traditional

    full page →fda device 510k ↗
    ›Jan 23, 2025device 510k566d agoCyncronus, LLC — CephNinja (510k cleared)

    Product code: LLZ. Advisory committee: Radiology. Type: Traditional

    full page →fda device 510k ↗
    ›Jan 23, 2025device 510k566d agoTerarecon,Inc. — TeraRecon Aorta.CT (1.1.0) (510k cleared)

    Product code: QIH. Advisory committee: Radiology. Type: Traditional

    full page →fda device 510k ↗
    ›Jan 23, 2025device 510k566d agoMurata Vios, Inc. — Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software 2050 (510k cleared)

    Product code: DXN. Advisory committee: Cardiovascular. Type: Traditional

    full page →fda device 510k ↗
    ›Jan 23, 2025device 510k566d agoAuris Health, Inc. — MONARCH™ Platform (MON-000008) (510k cleared)

    Product code: EOQ. Advisory committee: Ear, Nose, Throat. Type: Traditional

    full page →fda device 510k ↗
    ›Jan 24, 2025approval565d agoMEKINIST (TRAMETINIB) — FDA approvalSpexotras

    Sponsor: NOVARTIS. Form: SOLUTION. Route: ORAL

    full page →Spexotras →fda approvals ↗
    ›Jan 24, 2025approval565d agoMEKINIST (TRAMETINIB DIMETHYL SULFOXIDE) — FDA approvalSpexotras

    Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

    full page →Spexotras →fda approvals ↗
    ›Jan 24, 2025approval565d agoLEQEMBI (LECANEMAB-IRMB) — FDA approvallecanemab

    Sponsor: EISAI INC. Form: INJECTABLE. Route: INJECTION

    full page →lecanemab →fda approvals ↗
    ›Jan 24, 2025approval565d agoAVTOZMA (TOCILIZUMAB-ANOH) — FDA approvalAVTOZMA

    Sponsor: CELLTRION INC. Form: INJECTABLE. Route: INTRAVENOUS

    full page →AVTOZMA →fda approvals ↗
    ›Jan 24, 2025device 510k565d agoBridge TO Life, Ltd. — OrganProtex HTK Solution (510k cleared)

    Product code: KDL. Advisory committee: Gastroenterology, Urology. Type: Traditional

    full page →fda device 510k ↗
    ›Jan 24, 2025device 510k565d agoIndiba S. A. U. — Indiba Diathermia Radiofrequency Deep Care Device (Deep care IDC0409/EVONY ); Indiba Diathermia Radiofrequency Activ Device (Activ ACT0309/CT9) (510k cleared)

    Product code: PBX. Advisory committee: General, Plastic Surgery. Type: Traditional

    full page →fda device 510k ↗
    ›Jan 24, 2025device 510k565d agoRoche Diagnostics Operations — Tina-quant Lipoprotein(a) Gen.2 Molarity (510k cleared)Dawn Sea Therapeutics

    Product code: DFC. Advisory committee: Immunology. Type: Traditional

    full page →fda device 510k ↗
    ›Jan 24, 2025device 510k565d agoZhejiang Curaway Medical Technology Co., Ltd. — Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle (510k cleared)Zhejiang Xinkanghe Biomedical Technology Co Ltd

    Product code: KNW. Advisory committee: Gastroenterology, Urology. Type: Traditional

    full page →fda device 510k ↗
    ›Jan 24, 2025device 510k565d agoElliquence, LLC — AxCess® Expandable Interbody System (510k cleared)

    Product code: MAX. Advisory committee: Orthopedic. Type: Traditional

    full page →fda device 510k ↗
    ›Jan 24, 2025device 510k565d agoZhejiang Curaway Medical Technology Co., Ltd. — Bone Marrow Biopsy Needle (510k cleared)Zhejiang Xinkanghe Biomedical Technology Co Ltd

    Product code: KNW. Advisory committee: Gastroenterology, Urology. Type: Traditional

    full page →fda device 510k ↗
    ›Jan 24, 2025device 510k565d agoClearPoint Neuro, Inc. — ClearPoint System (Software Version 3.0) (510k cleared)ClearPoint Neuro, Inc.

    Product code: HAW. Advisory committee: Neurology. Type: Traditional

    full page →fda device 510k ↗
    ›Jan 24, 2025device 510k565d agoIbex Medical Analytics , Ltd. — Galen™ Second Read™ (510k cleared)

    Product code: QPN. Advisory committee: Pathology. Type: Traditional

    full page →fda device 510k ↗
    ›Jan 24, 2025device 510k565d agoMagentiq Eye, Ltd. — MAGENTIQ-COLO (ME-APDS) (510k cleared)

    Product code: QNP. Advisory committee: Gastroenterology, Urology. Type: Special

    full page →fda device 510k ↗
    ›Jan 24, 2025device 510k565d agoWuhan Guangdun Technology Co.,Ltd.. — Enhanced Handheld Pain Relief Laser Instrument (GD-P-E) (510k cleared)

    Product code: NHN. Advisory committee: Physical Medicine. Type: Traditional

    full page →fda device 510k ↗
    ›Jan 26, 2025approval563d agoNIZORAL ANTI-DANDRUFF (KETOCONAZOLE) — FDA approvalTeva Pharmaceuticals USA Inc

    Sponsor: KRAMER. Form: SHAMPOO. Route: TOPICAL

    full page →fda approvals ↗

    Week of Jan 27, 2025

    7
    ›Jan 27, 2025approval562d agoCARBAMAZEPINE — FDA approvalcarbamazepine ER

    Sponsor: TORRENT PHARMS. Form: TABLET, CHEWABLE. Route: ORAL

    full page →carbamazepine ER →fda approvals ↗
    ›Jan 27, 2025approval
    ← prev
    page 6 of 435
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    562d ago
    CARBAMAZEPINE — FDA approvalcarbamazepine ER

    Sponsor: TORRENT PHARMS. Form: TABLET. Route: ORAL

    full page →carbamazepine ER →fda approvals ↗
    ›Jan 27, 2025approval562d agoCARBAMAZEPINE — FDA approvalcarbamazepine ER

    Sponsor: TORRENT PHARMS. Form: TABLET. Route: ORAL

    full page →carbamazepine ER →fda approvals ↗
    ›Jan 27, 2025approval562d agoENHERTU (FAM-TRASTUZUMAB DERUXTECAN-NXKI) — FDA approvaltrastuzumab deruxtecan

    Sponsor: DAIICHI SANKYO. Form: INJECTABLE. Route: INJECTION

    full page →trastuzumab deruxtecan →fda approvals ↗
    ›Jan 27, 2025approval562d agoENHERTU (FAM-TRASTUZUMAB DERUXTECAN-NXKI) — FDA approvaltrastuzumab deruxtecan

    Sponsor: DAIICHI SANKYO. Form: INJECTABLE. Route: INJECTION

    full page →trastuzumab deruxtecan →fda approvals ↗
    ›Jan 27, 2025device 510k562d agoBeijing Sano Laser S&T Development Co.,Ltd — CO2 Laser Therapy Systems (SHE-LSP003-1) (510k cleared)

    Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional

    full page →fda device 510k ↗
    ›Jan 27, 2025device 510k562d agoFirstar Dental Company — Firstar Dental Unit (510k cleared)

    Product code: EIA. Advisory committee: Dental. Type: Traditional

    full page →fda device 510k ↗
    $CLPT
    $NVS155.21-1.01%
    $NVS155.21-1.01%
    $ABBV249.50+0.61%
    $ABBV249.50+0.61%
    $ICUI183.41+0.54%
    $ABBV249.50+0.61%